BEUDAMED
    FDA Enforcement Class II Ongoing

    VITROS Immunodiagnostic Products Troponin I ES Calibrators

    Recall: Z-2358-2023 · Reported August 16, 2023

    Enforcement

    Recall Number
    Z-2358-2023
    Event ID
    92662
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ORTHO-CLINICAL DIAGNOSTICS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 16, 2023
    Initiation Date
    June 5, 2023
    Classification Date
    August 8, 2023
    Address
    Felindre Meadows, N/A, Bridgend, N/A, N/A, United Kingdom

    Description

    VITROS Immunodiagnostic Products Troponin I ES Calibrators

    Reason

    Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.

    Code Info

    Product Code: 6802302; UDI-DI: 10758750002511; Lot No.: 4800; Expiration Date: 10-Jun-2023.

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    4,013 units